Motion control and vertebral fixation device

ABSTRACT

A vertebral fixation plate assembly for securing adjacent vertebral bodies is provided that is configured to distract or extend along its length, as well as provide multiple degrees of freedom between the fixation points and the vertebral fixation plate in order to accommodate different installation locations, as well as different surgical approaches. Methods of using the vertebral fixation plate assembly are also provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/940,484 filed Mar. 19, 2018, the entirety of which is incorporatedherein by reference.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to afixation device and methods of use for stabilizing the spine.

BACKGROUND

Spinal disorders such as degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvatureabnormalities, kyphosis, tumor, and fracture may result from factorsincluding trauma, disease and degenerative conditions caused by injuryand aging. Spinal disorders typically result in symptoms including pain,nerve damage, and partial or complete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes fusion, fixation, correction, discectomy, laminectomy andimplantable prosthetics. Fixation of vertebrae is a common approach totreating various types of spinal disorders. In general terms, one ormore vertebrae are typically fixed in position relative to one or moreother vertebrae. Conventional anterior spinal fixation plates typicallyinclude a unitary plate having a pair of bone screw openings at oppositeends. These plates may be adjustable, but are sometimes awkward to use,expensive to manufacture, and have larger profiles. The plates may havecomplex adjustment mechanisms that make adjustment difficult duringsurgical procedures.

The present invention seeks to address these and other shortcomings inthe existing art.

SUMMARY

In one aspect, the present disclosure provides a vertebral fixationplate assembly comprising a first plate having an inward side and anoutward side, the first plate comprising a fixation end and a tongue endextending therefrom, wherein the tongue end comprises an elongatedaperture extending between the inward side and the outward side; and asecond plate having an inward side and an outward side, the second platecomprising a fixation end and a recessed end extending therefrom,wherein the recessed end comprises a recess adapted to receive thetongue end of the first plate, and wherein the inward side of therecessed plate comprises an inward aperture therethrough and the outwardside of the recessed plate comprises an outward aperture therethrough.

In some embodiments, the length of the vertebral fixation plate assemblymay be adjusted by translating the tongue end of the first plate withinthe recess of the recessed end of the second plate. In some embodiments,the elongated aperture comprises a first opening on the inward side anda second opening on the outward side and a face between the firstopening and second opening, and wherein the width of the second openingis larger than the width of the first opening.

In some embodiments, the vertebral fixation plate assembly furthercomprises a set screw, wherein the set screw is disposed within theoutward aperture and inward aperture of the second plate and through theelongated aperture of the first plate. In some embodiments, the setscrew comprises an angled portion configured to contact the face betweenthe first and second opening, whereby the length of the vertebralfixation plate is fixed.

In some embodiments, at least one of the first plate or second plate isshaped to accommodate a curve of a vertebral body. In some embodiments,both the first plate and the second plate are shaped to accommodate acurve of a vertebral body.

In some embodiment, at least one of the fixation end of the first plateor the fixation end of the second plate comprises a fixation endaperture between the inward side and outward side. In some embodiments,the fixation end aperture comprises a collar disposed within thefixation end aperture.

In some embodiments, the vertebral fixation plate assembly furthercomprises at least one staple, wherein the staple comprises a baseportion comprising at least one prong extending therefrom and a curvedouter portion, and wherein the curved outer portion is configured to bereceived by the collar to secure the staple to the first plate or secondplate. In some embodiments, the collar and the curved outer portion ofthe staple form a ball joint having at least, for example two, orpreferably three, degrees of rotational freedom, wherein the at leasttwo, or preferably three, degrees of rotational freedom are selectedfrom roll, pitch, and yaw. In some embodiments, the at least two degreesof rotational freedom are pitch and yaw, and wherein the ball jointprovides up to 15° of pitch and up to 15° of yaw. In some embodiments,the curved outer portion of the staple is received by the collar using asnap-fit connection. In some embodiments, the staple comprises a bonescrew aperture.

In some embodiments, the vertebral fixation plate assembly furthercomprises a lock screw configured to be received within the fixation endaperture to secure the position of the staple relative to the fixationend aperture by restricting one or more of the at least two, orpreferably three, degrees of rotational freedom.

The present disclosure also provides a vertebral fixation plateassembly, comprising a first plate having an inward side and an outwardside, the first plate comprising a fixation end and a tongue endextending therefrom, wherein the tongue end comprises an elongatedaperture extending between the inward side and the outward side, andwherein the fixation end of the first plate comprises a first platefixation end aperture between the inward side and outward side, whereinthe first plate fixation end aperture comprises a first collar disposedwithin the first plate fixation end aperture; a second plate having aninward side and an outward side, the second plate comprising a fixationend and a recessed end extending therefrom, wherein the recessed endcomprises a recess adapted to receive the tongue end of the first plate,and wherein the inward side of the recessed plate comprises an inwardaperture therethrough and the outward side of the recessed platecomprises an outward aperture therethrough, and wherein the fixation endof the second plate comprises a first plate fixation end aperturebetween the inward side and outward side, wherein the second platefixation end aperture comprises a second collar disposed within thesecond plate fixation end aperture; a first staple, wherein the firststaple comprises a base portion comprising at least one prong extendingtherefrom and a curved outer portion, and wherein the curved outerportion is configured to be received by the first collar to secure thefirst staple to the first plate; and a first second, wherein the secondstaple comprises a base portion comprising at least one prong extendingtherefrom and a curved outer portion, and wherein the curved outerportion is configured to be received by the second collar to secure thesecond staple to the second plate.

In another aspect, the present disclosure provides a method ofinstalling a vertebral fixation plate assembly, the method comprisingproviding a first staple, wherein the first staple comprises a baseportion comprising at least one prong extending therefrom and a curvedouter portion and an aperture through the curved outer portion and thebase portion; inserting a first bone screw through the aperture of thefirst staple to secure the first staple to a first vertebral body;providing a second staple, wherein the second staple comprises a baseportion comprising at least one prong extending therefrom and a curvedouter portion and an aperture through the curved outer portion and thebase portion; inserting a second bone screw through the aperture of thefirst staple to secure the second staple to a second vertebral bodyadjacent to the first vertebral body; providing a vertebral fixationplate, the vertebral fixation plate comprising a first plate having aninward side and an outward side, the first plate comprising a fixationend and a tongue end extending therefrom, wherein the tongue endcomprises an elongated aperture extending between the inward side andthe outward side, and wherein the fixation end of the first platecomprises a first plate fixation end aperture between the inward sideand outward side, wherein the first plate fixation end aperturecomprises a first collar disposed within the first plate fixation endaperture; and a second plate having an inward side and an outward side,the second plate comprising a fixation end and a recessed end extendingtherefrom, wherein the recessed end comprises a recess adapted toreceive the tongue end of the first plate, and wherein the inward sideof the recessed plate comprises an inward aperture therethrough and theoutward side of the recessed plate comprises an outward aperturetherethrough, wherein the fixation end of the second plate comprises afirst plate fixation end aperture between the inward side and outwardside, wherein the second plate fixation end aperture comprises a secondcollar disposed within the second plate fixation end aperture; andengaging the first staple within the first plate fixation end apertureto attach the first plate to the first staple; and engaging the secondstaple within the second plate fixation end aperture to attach thesecond plate to the second staple.

In some embodiments, the method further comprises adjusting the lordoticangle between the first and second vertebral bodies, whereby the lengthof the vertebral fixation plate is changed. In some embodiments, themethod further comprises inserting a set screw within the outwardaperture and inward aperture of the second plate and through theelongated aperture of the first plate, whereby the length of thevertebral fixation plate is fixed. In some embodiments, the methodfurther comprises inserting a first lock screw into the first platefixation end aperture, whereby the relative position between the firststaple and the first plate is fixed; and inserting a second lock screwinto the second plate fixation end aperture, whereby the relativeposition between the second staple and the second plate is fixed.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure is further informed by the specific descriptionaccompanied by the following drawings, in which:

FIG. 1 is a perspective view of a representative vertebral fixationplate assembly in accordance with the principles of the presentdisclosure;

FIG. 2 is a perspective view of a representative vertebral fixationplate assembly in accordance with the principles of the presentdisclosure;

FIG. 3 is a perspective view of a representative vertebral fixationplate assembly installed at (A) a low lordotic angle and (B) a largelordotic angle in accordance with the principles of the presentdisclosure;

FIG. 4 Is a perspective view of the (A) outward side and (B) inward sideof a representative vertebral fixation plate in accordance with theprinciples of the present disclosure;

FIG. 5 is a perspective view of the inward side of a representativevertebral fixation plate assembly in accordance with the principles ofthe present disclosure;

FIG. 6 is a side cut-away view of a representative vertebral fixationplate assembly in accordance with the principles of the presentdisclosure;

FIG. 7 is a close-up side cut-away view of a representative vertebralfixation plate aperture, staple, and bone screw in accordance with theprinciples of the present disclosure; and

FIG. 8 shows the steps (A)-(D) of a method of installing a vertebralfixation plate assembly in accordance with the principles of the presentdisclosure

DETAILED DESCRIPTION

The exemplary embodiments of the surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a vertebral fixation plate for use during various spinal proceduresand that may be used in conjunction with other devices and instrumentsrelated to spinal treatment, such as spinal implants (e.g., expandablespinal implants), insertion instruments, specialized instruments suchas, for example, expandable retractors and spinal surgical tables thatrotate and bend the patient in various directions, and/or a method ormethods for treating a spine, such as the tables, patient positioningframes, and the like, and related methods of using them include thosedescribed in, e.g., U.S. patent application Ser. Nos. 15/239,239,15/239,256, 15/337,157, 15/638,802, 15/639,080, 15/672,005, and15/674,456, all incorporated herein by reference in their entirety.

In some embodiments, the present system includes a vertebral bone plateassembly suitable for use in various spinal procedures, in particular adirect lateral interbody fusion (sometimes referred to as DLIFprocedures), oblique lateral interbody fusion (sometimes referred to asOLIF procedures), and anterior lumbar interbody fusions (sometimesreferred to as ALIF procedures), or variations of these procedures inwhich the present bone plate assembly is secured to adjacent vertebralbodies to stabilize at least one vertebral level and may further help tosecure an intervertebral implant, including, for example, by connectingto the intervertebral implant by pin, screw, or other fixation device orby physically blocking the retropulsion of the intervertebral implant.

The present disclosure may be understood more readily by reference tothe following detailed description of the embodiments taken inconnection with the accompanying drawing figures, which form a part ofthis disclosure. It is to be understood that this application is notlimited to the specific devices, methods, conditions or parametersdescribed and/or shown herein, and that the terminology used herein isfor the purpose of describing particular embodiments by way of exampleonly and is not intended to be limiting. In some embodiments, as used inthe specification and including the appended claims, the singular forms“a,” “an,” and “the” include the plural, and reference to a particularnumerical value includes at least that particular value, unless thecontext clearly dictates otherwise. Ranges may be expressed herein asfrom “about” or “approximately” one particular value and/or to “about”or “approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”. Generally, similar spatial references ofdifferent aspects or components indicate similar spatial orientationand/or positioning, i.e., that each “first end” is situated on ordirected towards the same end of the device. Further, the use of variousspatial terminology herein should not be interpreted to limit thevarious insertion techniques or orientations of the implant relative tothe positions in the spine.

The following discussion includes a description of a vertebral fixationplate, related components and methods of employing the vertebralfixation plate in accordance with the principles of the presentdisclosure. Reference is made in detail to the exemplary embodiments ofthe present disclosure, which are illustrated in the accompanyingfigures. Turning to FIGS. 1-8 there are illustrated components of asurgical system, such as, for example, a vertebral fixation plateassembly 10.

The components of the vertebral fixation plate described herein can befabricated from biologically acceptable materials suitable for medicalapplications, including metals, synthetic polymers, ceramics and bonematerial and/or their composites. For example, the components of thevertebral fixation plate, individually or collectively, can befabricated from materials such as stainless steel alloys, commerciallypure titanium, titanium alloys, Grade 5 titanium, super-elastic titaniumalloys, cobalt-chrome alloys, stainless steel alloys, superelasticmetallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUMMETAL®), ceramics and composites thereof such as calcium phosphate(e.g., SKELITE™), thermoplastics such as polyaryletherketone (PAEK)including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) andpolyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄ polymericrubbers, polyethylene terephthalate (PET), fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone materialincluding autograft, allograft, xenograft or transgenic cortical and/orcorticocancellous bone, and tissue growth or differentiation factors,partially resorbable materials, such as, for example, composites ofmetals and calcium-based ceramics, composites of PEEK and calcium basedceramics, composites of PEEK with resorbable polymers, totallyresorbable materials, such as, for example, calcium based ceramics suchas calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite(HA)-TCP, calcium sulfate, or other resorbable polymers such aspolyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe andtheir combinations.

Various components of the vertebral fixation plate may be formed orconstructed material composites, including the above materials, toachieve various desired characteristics such as strength, rigidity,elasticity, compliance, biomechanical performance, durability andradiolucency or imaging preference. The components of the presentvertebral fixation plate, individually or collectively, may also befabricated from a heterogeneous material such as a combination of two ormore of the above-described materials. The components of the vertebralfixation plate may be monolithically formed, integrally connected orinclude fastening elements and/or instruments, as described herein. Thecomponents of the vertebral fixation plate may be formed using a varietyof subtractive and additive manufacturing techniques, including, but notlimited to machining, milling, extruding, molding, 3D-printing,sintering, coating, vapor deposition, and laser/beam melting.Furthermore, various components of the vertebral fixation plate may becoated or treated with a variety of additives or coatings to improvebiocompatibility, bone growth promotion or other features. To the extentthe plate is entirely or partially radiolucent, it may further includeradiographic markers made, for example of metallic pins, at one or bothends, on each corner of the ends, and/or along the length of the implantin various locations including near the center of the assembly.

The vertebral fixation plate may be employed, for example, with aminimally invasive procedure, including percutaneous techniques,mini-open and open surgical techniques to deliver and introduceinstrumentation and/or one or more spinal implants at a surgical sitewithin a body of a patient, for example, a section of a spine. In someembodiments, the vertebral fixation plate may be employed with surgicalprocedures, as described herein, and/or, for example, corpectomy,discectomy, fusion and/or fixation treatments that employ spinalimplants to restore the mechanical support function of vertebrae. Insome embodiments, the expandable spinal implant system may be employedwith surgical approaches, including but not limited to: anterior lumbarinterbody fusion (ALIF), direct lateral interbody fusion (DLIF), obliquelateral lumbar interbody fusion (OLLIF), oblique lateral interbodyfusion (OLIF), various types of anterior fusion procedures, and anyfusion procedure in any portion of the spinal column (sacral, lumbar,thoracic, and cervical, for example). The vertebral fixation plate may,in certain embodiments, additionally or alternatively be concave orconvexly curved in whole or in part to match or approximate thecurvature of the spinal segment or bony location where it is beingapplied.

Referring now to FIG. 1, a representative vertebral fixation plateassembly 10 is illustrated that is operable to be connected using bonescrews 20 to vertebral bodies 12 of a spine 14 to provide alignment andstability. The vertebral fixation plate assembly 10 may be used as anadjunct to fusion of adjacent vertebral bodies 12 or as an adjunct toother surgical procedures performed on the spine 14, or for othergeneral orthopedic uses throughout the body on various bones, includingthose described above. In the depicted embodiment, the vertebralfixation plate assembly has been installed at an oblique position.Various design aspects, as discussed more fully below, allow a vertebralfixation plate assembly of the present disclosure to be positioned inthe lateral plane, anterior plane, or any oblique plane between the two.For example, a vertebral fixation plate assembly of the presentdisclosure is depicted in a lateral position in FIG. 2. The vertebralfixation plate assembly 10 is being used in conjunction with anexpandable spinal implant 30 that may be expanded through a range ofangles to provide lordotic or kyphotic correction. Since the spinalimplant 30 may provide a range of different lordotic or kyphoticcorrection angles according the particular needs of a patient during anyparticular procedure, and further because the size of vertebral bodies12 and the spacing between vertebral bodies 12 varies from patient topatient, the vertebral fixation plate assembly 10 is operable to beincrementally adjusted to fit various size ranges, as shown in FIGS. 3Aand 3B. In FIG. 3A, spinal implant 30 is shown in a closed, collapsed,or partially expanded state, whereas in FIG. 3B, spinal implant 30 hasbeen expanded to provide a larger angle of correction a. Vertebralfixation plate assembly 10 is configured to distract or extend along itslength, as well as provide multiple degrees of freedom between thefixation points and vertebral fixation plate 10, in order to accommodatethe different orientations required by each scenario. During theoperative procedure while the appropriate adjustments to the spine arebeing made, e.g., increasing the lordotic angle, the vertebral fixationplate assembly restricts the range of distraction and angulation of thespine in the coronal, sagittal and transverse planes so as to ensure nounnecessary trauma occurs.

Referring now to FIGS. 4A and 4B, the vertebral fixation plate assembly10 includes a first plate 100 and a second plate 200. The second plate200 is designed to slide over the first plate 100 so as to allowtranslation of the two plates relative to each other and provide anadjustable length of the vertebral fixation plate 10.

First plate 100 comprises a fixation end 110 and a tongue end 120 thatextends therefrom. The fixation end 110 may be substantially planar andhave an inward side 112, i.e., the side adjacent the vertebral body, andan outward side 114, i.e., the side away from the vertebral body. In thedepicted embodiment, the fixation end is generally square, although theprecise shape of fixation end may be varied without substantiallyinterfering with the use of the device. The tongue end 120 is alsosubstantially planar and has an inward side 122 and an outward side 124and extends from a side of the fixation end. In some embodiments, tongueend 120 may extend at an angle, and/or be curved at least in part, fromthe fixation end 110 such that the tongue end 120 and fixation end 110are not co-planar. The angle between the tongue end 120 and fixation end110 may, for example, be between 0° and 30°, or preferably between 15°and 25°, as measured between the planes of outward sides 114 and 124.The tongue end 120 may be somewhat smaller in width and height than thefixation end 110.

Second plate 200 comprises a fixation end 210 and a recessed end 220that extends therefrom. The fixation end 210 may be substantiallyplanar, and/or curved at least in part, and have an inward side 212,i.e., the side adjacent the vertebral body, and an outward side 214,i.e., the side away from the vertebral body. In the depicted embodiment,the fixation end is generally square, although the precise shape offixation end may be varied without substantially interfering with theuse of the device. The recessed end 220 is also substantially planar,and/or curved at least in part, and has an inward side 222 and anoutward side 224 and extends from a side of the fixation end. In someembodiments, recessed end 220 may extend at an angle from the fixationend 210 such that the recessed end 220 and fixation end 210 are notco-planar. The angle between the recessed end 220 and fixation end 210may, for example, be between 0° and 30°, or preferably between 15° and25°, as measured between the planes of outward sides 214 and 224. Insome embodiments, the angle between fixation end 210 and recessed end220 of second plate 200 is substantially the same as the angle betweenfixation end 110 and tongue end 120 of first plate 100.

In some embodiments, as shown in FIG. 6, recessed end 220 comprises arecessed portion 225 that is shaped to fit or slide over the tongue end120 of first plate 100. The outer dimensions of the recessed end 220 maybe substantially the same as those of fixation end 210, while therecessed portion is somewhat smaller in width and height andsubstantially the same size as tongue end 120. The depth of recess 225is designed to accommodate the full length of tongue end 120 wheninserted. First plate 100 and second plate 200 may be distracted, withtongue end 120 translating within recess 225, so as to lengthen andshorten the vertebral fixation plate assembly 10.

When the desired length of the device is achieved, the tongue end 120and recessed end 220 may be secured via a set screw 300 in order to fixthe length of the vertebral fixation plate assembly 10. As shown in FIG.4A, tongue end 120 may comprise an elongated aperture 126 between inwardside 122 and outward side 124 to accommodate set screw 300 along thelength of tongue end 120. In some embodiments, the elongated aperturecomprises a first opening 122 a on the inward side and a second openingon the outward side 124 a and a face 127 between the first opening 122 aand second opening 124 a, and the width of the second opening 124 a islarger than the width of the first opening 122 a. As can be seen fromthe figures, face 127 is, for example, oriented at an angle to inwardside 122 and outward side 124. In some embodiments, this angle may be0°, i.e., perpendicular to inward side 122 and outward side 124, to 60°.Recessed end 220 may also comprise a threaded aperture in each of inwardside 222 and outward side 224 to accommodate set screw 300. In thedepicted embodiment of FIG. 6, the aperture 222 a through inward side222 is smaller than the aperture 224 a through outward side 224 so as toaccommodate the particular design of the shown set screw 300. Set screw300 comprises a threaded first end 310 sized so as to engage with thethreaded aperture 222 a in inward side 222 and a threaded second end 320sized so as to engage with the threaded aperture 224 a in outward side224. Due to the size differences of first end 310 and second end 320,the middle portion of set screw 300, may, for example, include an angledportion 330. In some embodiments, the angled portion 330 is designed toengage with face 127 of tongue end 120 of first plate 100 and provide amore secure fixation. The engagement between the outer threaded surfacesof set screw 300 and the threaded inner surfaces of apertures 226 and228 may be via pitch lock, major/minor lock, or any other thread/pitchinterface.

The vertebral fixation plate assembly 10 may be secured to the vertebralbodies 12 with staples 400 and bone screws 20, as depicted in FIG. 7.Staples 400 may comprise a base portion 410 and a curved outer portion420. Base portion 410 is designed to contact vertebral bodies 12, andmay further comprise at least one pin 412 extending therefrom to engagevertebral bodies 12, as shown in FIGS. 5 and 7. Fixation end 110 offirst plate 100 may comprise an aperture 116 between the inward side 112and outward side 114 to hold and receive a staple 400, as shown in FIG.6. Fixation end 210 of second plate 200 may comprise a similar aperture216 to hold and receive a staple 400. Staples 400 are configured to fitwithin apertures 116, 216 and provide, for example, up to at least, forexample, two or three degrees of rotational freedom relative to firstplate 100 and second plate 200. Curved outer portion 420 of staple 400is designed to be engaged with a collar 117 within aperture 116, asshown in FIGS. 4B and 7. A similar collar 217 may be disposed withinaperture 216, as shown in FIG. 4B. In some embodiments, curved outerportion 420 of staple 400 is secured within apertures 116, 216 via asnap-fit connection. The interaction between curved outer portion 420and collars 117, 217 functions as a ball joint, allowing the staple 400to rotate freely, i.e., roll, within aperture 116, 216 (as depicted byarrows R in FIG. 5), as well as experience pitch (P) and yaw (Y). Insome embodiments, the movement of the staple 400 is, for example,limited to 15° in the pitch and yaw directions. In other embodiments,the staple 400 may, for example, be allowed more freedom of movement,such as 20°, 25°, 30°, or more. The freedom of movement between plates100, 200 and staples 400 allows the vertebral fixation plate assembly 10to be used at a variety of different lengths and orientations to thevertebral bodies, i.e., anteriorly, laterally, or obliquely. Theorientation between the staple 400 and plate 100 or 200 may be lockedusing a lock screw 500, as shown in FIGS. 4A, B, and 6. Alternatively,in place of lock screw 500, a cap, cam, wire, spring, adhesive, orlocking plate may be incorporated into the plate. Lock screw 500 maycomprise a walled portion 510 having external threads and recessedinternal portion 520. The external threads of walled portion 510 engagecomplimentary threading within apertures 116, 216. The curved outerportion 420 of staple 400 fits within the recessed internal portion 520of walled portion 510 such that walled portion 510 is disposed betweenstaple 400 and the internal wall of apertures 116, 216, thereby securingthe ball joint and fixing the relative position of staple 400 and plate100 or 200.

As shown in FIG. 7, staples 400 may further comprise an aperture 430therethrough to hold and receive and bone screw 20. The aperture 430 mayinclude a spherical recessed portion 432 that allows a spherical head 22of a bone screw 20 to be recessed in the apertures 430. The sphericalhead 22 of bone screw 20 may include one or more ridges or steps 24 forinterfacing with the lock screw 500 for a tighter fit. Before the lockscrew 500 is tightened the bone screw 20 may be free to move and/orrotate in one or more axis.

Another aspect of the present invention discloses a method forstabilizing at least two adjacent vertebral bodies 12 in a spine 14using a vertebral fixation plate assembly of the present disclosure. Asdepicted in FIGS. 8A-D, a spinal implant 30 has been placed within theintervertebral space between two adjacent vertebral bodies 12. Exemplaryspinal implants include, e.g., U.S. Ser. No. 62/633,952 and U.S.62/634,033, both incorporated herein by reference in their entirety, andmay include other expandable or non-expandable implants, such as, forexample, U.S. Ser. Nos. 14/532,636, 14/885,472, 14/047,563, 14/096,769,14/203,125, and U.S. Pat. Nos. 8,628,578 and 7,828,849, eachincorporated herein in their entirety, implanted unilaterally orbilaterally. In the depicted embodiment, spinal implant 30 is anexpandable implant and allows for an adjustment to the desired lordoticangle after insertion into the intervertebral space. The spinal implantmay be placed through spinal procedures as known in the art, includinganterior lumbar interbody fusion (ALIF), direct lateral interbody fusion(DLIF), oblique lateral lumbar interbody fusion (OLLIF), oblique lateralinterbody fusion (OLIF), various types of anterior fusion procedures,and any fusion procedure in any portion of the spinal column (sacral,lumbar, thoracic, and cervical, for example). The staples 400 are thenplaced into each adjacent vertebral body, as shown in FIGS. 8B and 8C,and secured with bone screws 20. The length of the vertebral fixationplate assembly 10 is adjusted as necessary by distracting first plate100 from second plate 200. The vertebral fixation plate assembly 10 isthen attached by engaging staples 400 within apertures 116, 216, asshown in FIG. 8D. Alternatively, one or both of staples 400 may bepre-installed in the vertebral fixation plate assembly 10 beforeinsertion or attachment to the vertebra. Once in place, additionaladjustments can be made to the lordotic angle by, e.g., expanding spinalimplant 30 and/or articulating a surgical table, patient positioningframes, and the like, as described in, e.g., U.S. patent applicationSer. Nos. 15/239,239, 15/239,256, 15/337,157, 15/638,802, 15/639,080,15/672,005, and 15/674,456, all incorporated herein by reference intheir entirety. As the lordotic angle is adjusted, the range of motionprovided by the ball joint interaction of curved outer surface 310 ofstaples 300 and apertures 116 and 216 allows the vertebral fixationplate assembly 10 to distract or shorten as the length is adjusted. Atthe same time, the vertebral fixation plate assembly restricts the rangeof distraction and angulation of the spine in the coronal, sagittal andtransverse planes so as to ensure no unnecessary trauma occurs. Once theappropriate lordotic angle is obtained, the length of the vertebralfixation plate assembly 10 may be secured by set screw 300, and theorientation of the first and second plates relative to the staples maybe secured by lock screws 500. In some embodiments, additional vertebralfixation plate assemblies may be used to secure multiple vertebrallevels. The set screw 300 may be tightened or loosened at various timesduring a surgical procedure to provide stability during the procedure asthe spine or patient are moved or other portions of the procedure areperformed, and to adjust the correction and realignment of thevertebrae.

A medical practitioner obtains access to a surgical site includingvertebrae such as through incision and retraction of tissues. Spinalimplant systems of the present disclosure can be used in any existingsurgical method or technique including open surgery, mini-open surgery,minimally invasive surgery and percutaneous surgical implantation,whereby vertebrae are accessed through a mini-incision, retractor, tubeor sleeve that provides a protected passageway to the area, including,for example, an expandable retractor wherein the sleeve is formed frommultiple portions that may be moved apart or together and may beinserted with the portions closed or together and then expanded to allowfor insertion of implants of larger size than the closed cross sectionof the unexpanded retractor portions. In one embodiment, the componentsof the spinal implant system are delivered through a surgical pathway tothe surgical site along a surgical approach into intervertebral discspace between vertebrae. Various surgical approaches and pathways may beused. Unilateral approaches such as a transforaminal lumbar interbodyfusion (TLIF) approach may also be used to place the implant in asubstantially oblique position relative to the vertebrae. Multilateralapproaches such as those disclosed in U.S. Pat. No. 9,730,684,incorporated herein by reference in its entirety, may also be used withspinal implant systems of the present disclosure.

As will be appreciated by one of skill in the art, a preparationinstrument (not shown) may be employed to remove disc tissue, fluids,adjacent tissues and/or bone, and scrape and/or remove tissue fromendplate surfaces of the vertebrae in preparation for the proceduresutilizing a system of the present disclosure.

Components of a vertebral fixation plate of the present disclosure canbe delivered or implanted as a pre-assembled device or can be assembledin situ. Components of a vertebral fixation plate may be expanded,contracted, completely or partially revised, removed or replaced insitu. In some embodiments, one or all of the components of a vertebralfixation plate of the present disclosure can be delivered to thesurgical site via mechanical manipulation and/or a free hand technique.

In one embodiment, additional fastening elements, which may includelocking structure, configured for fixation with vertebrae to securejoint surfaces and provide complementary stabilization andimmobilization to a vertebral region. In some embodiments, lockingstructure may include fastening elements, such as, for example, rods,plates, clips, hooks, adhesives, cams, wires and/or flanges. Thecomponents of the vertebral fixation plate assembly can be made ofradiolucent materials such as polymers. Radiopaque markers may beincluded for identification under x-ray, fluoroscopy, CT or otherimaging techniques. The insertion instrument alone or with the tube forinsertion therethrough described above may be radiolucent and mayoptionally include markers added at the tip and/or along the length ofone or both of insertion instrument and the tube to permit them to beseen on fluoroscopy/x-ray while advancing into the patient. Thevertebral fixation plate, if radiolucent in whole or part, may alsoinclude one or more markers on each end, or in each corner, and/or invarious locations along the length of the plate to permit visualizationon X-ray or fluoroscopy or by other imaging devices.

In some embodiments, the use of microsurgical, minimally-invasive andimage guided technologies may be employed to access, view and repairspinal deterioration or damage, with the aid of spinal implant system.Upon completion of the procedure, the non-implanted components, surgicalinstruments and assemblies of spinal implant system may be removed andthe incision is closed. In some embodiments, the various instrumentsdisclosed may be provided with fiducial markers or other elementssuitable for use with surgical navigation systems (including, but notlimited to the STEALTHSTATION® Navigation system available fromMedtronic).

It will be understood that various modifications may be made to theembodiments disclosed herein. Other embodiments of the invention will beapparent to those skilled in the art from consideration of thespecification and practice of the invention disclosed herein. It isintended that the specification and examples be considered as exemplaryonly, with the true scope and spirit of the invention being indicated bythe following claims.

What is claimed is:
 1. A vertebral fixation plate apparatus forattachment to at least one vertebral body, comprising: a first platehaving a tongue end extending therefrom and a fixation end comprising afirst plate fixation end aperture; a second plate comprising a recessedend and a fixation end comprising a second plate fixation end aperture,wherein the recessed end comprises a recess adapted to receive thetongue end of the first plate; a bone screw configured to engage the atleast one vertebral body; a staple comprising a base portion having aprong extending therefrom, a curved outer portion, and a staple apertureadapted to receive the bone screw; and a lock screw configured to bereceived within one of the first plate fixation end aperture and thesecond plate fixation end aperture and comprising an external wallportion adapted to be disposed between the staple and the one of thefirst plate fixation end aperture and the second plate fixation endaperture to secure the position of the staple relative to the one of thefirst plate fixation end aperture and the second plate fixation endaperture.
 2. The vertebral fixation plate apparatus of claim 1, furthercomprising a collar disposed in one of the first plate fixation endaperture and the second plate fixation end aperture and adapted toreceive the staple.
 3. The vertebral fixation plate apparatus of claim2, wherein the collar is adapted to receive the curved outer portion ofthe staple to form a ball joint having at least two degrees ofrotational freedom selected from roll, pitch, and yaw.
 4. The vertebralfixation plate apparatus of claim 2, wherein: the curved outer portionof the staple is configured to be received in a snap-fit arrangement bythe collar to secure the staple to one of the first plate and the secondplate; and the collar and the curved outer portion of the staple form aball joint.
 5. The vertebral fixation plate apparatus of claim 2,wherein: the curved outer portion of the staple is configured to bereceived in a snap-fit arrangement by the collar to secure the staple toone of the first plate and the second plate; the collar is adapted toreceive the curved outer portion of the staple to form a ball jointhaving at least two degrees of rotational freedom selected from roll,pitch, and yaw; and the lock screw is configured to restrict one or moreof the at least two degrees of rotational freedom of the ball joint. 6.The vertebral fixation plate apparatus of claim 1, wherein: the bonescrew has a spherical head; and the staple aperture of the staplecomprises a spherical recessed portion adapted to receive the sphericalhead of the bone screw.
 7. The vertebral fixation plate apparatus ofclaim 2, wherein: the bone screw has a spherical head; the stapleaperture of the staple comprises a spherical recessed portion adapted toreceive the spherical head of the bone screw; and the collar is adaptedto receive the curved outer portion of the staple to form a ball jointhaving at least two degrees of rotational freedom selected from roll,pitch, and yaw.
 8. The vertebral fixation plate apparatus of claim 2,wherein: the bone screw has a spherical head; the staple aperture of thestaple comprises a spherical recessed portion adapted to receive thespherical head of the bone screw; the collar is adapted to receive thecurved outer portion of the staple to form a ball joint having at leasttwo degrees of rotational freedom selected from roll, pitch, and yaw;and the lock screw is configured to restrict one or more of the at leasttwo degrees of rotational freedom of the ball joint.
 9. The vertebralfixation plate apparatus of claim 1, further comprising: the lock screwhaving external threads; and one of the first plate fixation endaperture and the second plate fixation end aperture being threaded andadapted to threadingly receive the external threads of the lock screw.10. The vertebral fixation plate apparatus of claim 1, furthercomprising the lock screw defining a recessed internal portion adaptedto receive the curved outer portion of the staple.
 11. The vertebralfixation plate apparatus of claim 1, wherein: the tongue end of thefirst plate comprises an elongated aperture extending between inward andoutward sides of the first plate; an inward side of the second platecomprises a threaded inward aperture therethrough and an outward side ofthe second plate comprises a threaded outward aperture therethrough; andfurther comprising a set screw, the set screw comprising a threadedfirst end configured to engage with the threaded inward aperture of thesecond plate, a threaded second end configured to engage with thethreaded outward aperture of the second plate, and a middle portionconfigured to pass through the elongated aperture of the tongue end ofthe first plate.
 12. The vertebral fixation plate apparatus of claim 1,wherein the length of the vertebral fixation plate apparatus may beadjusted by translating the tongue end of the first plate within therecess of the recessed end of the second plate.
 13. A vertebral fixationplate apparatus for attachment to at least one vertebral body,comprising: a first plate having a tongue end extending therefrom and afixation end comprising a first plate fixation end aperture; a secondplate comprising a recessed end and a fixation end comprising a secondplate fixation end aperture, wherein the recessed end comprises a recessadapted to receive the tongue end of the first plate, wherein at leastone of the first plate fixation end aperture and the second platefixation end aperture comprises a collar disposed therein; at least onebone screw having a spherical head and adapted for engaging the at leastone vertebral body; at least one staple, wherein the at least one staplecomprises a base portion comprising a prong extending therefrom, astaple aperture therethrough comprising a spherical recessed portionadapted to receive the spherical head of the at least one bone screw,and a curved outer portion adapted to be received by a respectivecollar, wherein the collar and the curved outer portion form a balljoint having at least two degrees of rotational freedom selected fromroll, pitch, and yaw; and at least one lock screw configured to bereceived within the at least one of the first plate fixation endaperture and the second plate fixation end aperture and comprising anexternal wall portion adapted to be disposed between the at least onestaple and the at least one of the first plate fixation end aperture andthe second plate fixation end aperture to secure the position of the atleast one staple relative to the at least one of the first platefixation end aperture and the second plate fixation end aperture. 14.The vertebral fixation plate apparatus of claim 13, wherein: the tongueend of the first plate comprises an elongated aperture extending betweeninward and outward sides of the first plate; and an inward side of thesecond plate comprises a threaded inward aperture therethrough and anoutward side of the second plate comprises a threaded outward aperturein communication with the recess.
 15. The vertebral fixation plateapparatus of claim 14, further comprising a set screw, the set screwcomprising a threaded first end configured to engage with the threadedinward aperture of the second plate, a threaded second end configured toengage with the threaded outward aperture of the second plate, and amiddle portion configured to pass through the elongated aperture of thetongue end of the first plate.
 16. The vertebral fixation plateapparatus of claim 13, further comprising the at least one lock screwdefining a recessed internal portion adapted to receive the curved outerportion of the at least one staple.
 17. The vertebral fixation plateapparatus of claim 13, further comprising the spherical head of the atleast one bone screw having at least one ridge adapted for interfacingwith the at least one lock screw for a tighter fit.
 18. A vertebralfixation plate apparatus for attachment to at least one vertebral body,comprising: a first plate having a tongue end extending therefrom and afixation end comprising a first plate fixation end aperture; a secondplate comprising a recessed end and a fixation end comprising a secondplate fixation end aperture, wherein the recessed end comprises a recessadapted to receive the tongue end of the first plate; a first bone screwand a second bone screw, each being adapted for engaging the at leastone vertebral body; a first staple and a second staple, each comprisinga base portion having a prong extending therefrom, a curved outerportion, and a staple aperture adapted to receive one of the first bonescrew and the second bone screw; a first lock screw configured to bereceived within the first plate fixation end aperture and comprising anexternal wall portion adapted to be disposed between the first stapleand the first plate fixation end aperture to secure the position of thefirst staple relative to the first plate fixation end aperture; and asecond lock screw configured to be received within the second platefixation end aperture and comprising an external wall portion adapted tobe disposed between the second staple and the second plate fixation endaperture to secure the position of the second staple relative to thesecond plate fixation end aperture.
 19. The vertebral fixation plateapparatus of claim 18, further comprising a collar disposed within oneof the first plate fixation end aperture and the second plate fixationend aperture, wherein the collar is adapted to receive the curved outerportion of one of the first staple and the second staple to form a balljoint having at least two degrees of rotational freedom selected fromroll, pitch, and yaw.
 20. The vertebral fixation plate apparatus ofclaim 18, wherein at least one of the first bone screw and the secondbone screw has a spherical head; and the staple aperture of at least oneof the first staple and the second staple comprises a spherical recessedportion adapted to receive the spherical head of the at least one of thefirst bone screw and the second bone screw.